ADR that result in revision of patient information
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| The United Kingdom: Montelukast: reminder of the risk of neuropsychiatric reactions |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hallucinations, anxiety and depression, as well as changes in behaviour and mood. Healthcare professionals should advise patients and their caregivers to be alert to these risks and seek medical advice as soon as possible if neuropsychiatric reactions occur.
To increase awareness of the risks of neuropsychiatric effects with montelukast, new boxed warnings will be introduced to the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) to make these risks more prominent to the reader. These warnings have been updated with the current evidence on the risk. Healthcare professionals and patients should familiarise themselves with this information.
To increase awareness of the risks of neuropsychiatric effects with montelukast, new boxed warnings will be introduced to the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) to make these risks more prominent to the reader. These warnings have been updated with the current evidence on the risk. Healthcare professionals and patients should familiarise themselves with this information.
A range of neuropsychiatric reactions have been reported in association with montelukast. Among these are:
• sleep disturbances, depression and agitation including aggressive behaviour (may affect up to 1 in 100 people taking montelukast)
• disturbances of attention or memory (up to 1 in 1,000 people)
• very rarely, hallucinations and suicidal thinking and behaviour (up to 1 in 10,000 people)
Since first authorised in the United Kingdom (UK) in 1998, there have been approximately 44 million prescriptions of montelukast issued. During this time, MHRA has received 1,223 reports of suspected neuropsychiatric adverse reactions. Information on neuropsychiatric reactions with montelukast was first introduced in the SmPC in 2008 and a detailed warning was added in 2019.
Of these, the most frequently reported suspected neuropsychiatric reactions associated with montelukast for all age groups were sleep disorders, hallucinations, anxiety and depression, as well as changes in behaviour and mood. The most frequently reported reactions in younger children (up to and including 12 years old) were aggression, nightmares and anxiety while in older children (13 years old up to and including 17 years old) the most commonly reported were anxiety, suicidal ideation and depression.
Advice for healthcare professionals:
• the warnings in the Patient Information Leaflet and Summary of Product Characteristics for all montelukast products in the UK have been strengthened and highlighted with a black box for greater emphasis
• be alert for neuropsychiatric reactions in patients taking montelukast; events have been reported in adults, adolescents, and children
• discontinue montelukast if patients experience new or worsening symptoms of neuropsychiatric reactions
• advise patients and their caregivers to carefully read the list of neuropsychiatric reactions in the Patient Information Leaflet and to seek medical advice immediately should they occur
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/montelukast-reminder-of-the-risk-of-neuropsychiatric-reactions
In Hong Kong, there are 58 registered pharmaceutical products containing montelukast. All products are prescription-only medicines. So far, with regard to montelukast, the Department of Health (DH) has received 7 cases of adverse drug reaction, of which 5 cases were reported as neuropsychiatric reactions.
Related news on the risk of neuropsychiatric reactions associated with the use of montelukast was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 15 Jun 2009, with the latest update posted on 11 Dec 2020. Letters to remind local healthcare professionals were issued by the DH on 20 Sep 2019 and 5 Mar 2020. In Apr 2021, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided that the sales pack label and/or package insert of montelukast-containing products should include the relevant safety information. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Tuesday, Apr 30, 2024
Issued at HKT 18:30
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